Marginal note:Conditions

40. A source establishment may distribute cells, tissues or organs that have not been determined safe for transplantation if all of the following conditions are met:

• (a) a cell, tissue or organ that has been determined safe for transplantation is not immediately available;

• (b) the transplant physician or dentist, based on their clinical judgement, authorizes the exceptional distribution; and

• (c) the transplant establishment obtains the informed consent of the recipient.

Marginal note:Notice in source establishment’s records

• 41. (1) A source establishment that distributes cells, tissues or organs under section 40 must keep a copy of the notice of exceptional distribution in its records.

• Marginal note:Notice in transplant establishment’s records

  (2) The transplant establishment must keep a copy of the notice of exceptional distribution in its records.

• Marginal note:Contents of notice

  (3) A notice of exceptional distribution must contain all of the following information:

  • (a) the name of the transplanted cell, tissue or organ;

  • (b) the provisions of these Regulations with which the cell, tissue or organ is not in compliance at the time of its distribution;

  • (c) the justification for the distribution that formed the basis for the transplant physician’s or dentist’s decision to authorize it;

  • (d) the name of the source establishment that distributed the cell, tissue or organ;

  • (e) the name of the transplant establishment and of the transplant physician or dentist who authorized the distribution; and

  • (f) the time and date of the written authorization of the distribution and a copy of the authorization signed by the transplant physician or dentist.

Marginal note:Follow-up

42. A source establishment that distributes a cell, tissue or organ under section 40 before the donor suitability assessment is complete must, after the distribution, complete the assessment, carry out any other appropriate follow-up testing and notify the relevant transplant establishment of the results.

Marginal note:Required action

• 43. (1) Subject to subsection (2), an establishment that is not a source establishment and that has reasonable grounds to believe that the safety of a cell, tissue or organ that is or was in its possession has been compromised by the occurrence of an error or accident during processing must immediately take all of the following steps:

  • (a) determine the donor identification codes of all implicated cells, tissues and organs;

  • (b) identify and quarantine any other implicated cells, tissues and organs in its possession; and

  • (c) notify the following establishments:

    • (i) the relevant source establishment, and

    • (ii) if the cells, tissues or organs were imported, the establishment that imported them.

• Marginal note:Exception — importers

  (2) If the establishment that receives a notice under subsection (1) is the establishment that imported the implicated cells, tissues or organs, it only has to notify the source establishment.

• Marginal note:Contents of notice

  (3) The notice must include all of the following information:

  • (a) the reasons for the establishment’s belief that the safety of cells, tissues or organs has been compromised;

  • (b) an explanation of how the safety of the implicated cells, tissues or organs may have been compromised, if known;

  • (c) the donor identification codes of all implicated cells, tissues and organs; and

  • (d) the name of any suspected transmissible disease or disease agent, if known.

• Marginal note:Written notice

  (4) If the notice is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.